ays after start of treatment in the Zovirax Cream group and 3.4 days in the vehicle group (p=0.002). Overall, approximately 60% of patients started treatment at an early lesion stage (prodrome or erythema) and 40% at a late stage (papule or blister). The results were similar in both groups of patients.
5.2 Pharmacokinetic properties
Pharmacology studies have shown only minimal systemic absorption of aciclovir following repeated topical administration of Zovirax Cream.
5.3 Preclinical safety data
The results of a wide range of mutagenicity tests in vitro and in vivo indicate that aciclovir does not pose a genetic risk to man.
Aciclovir was not found to be carcinogenic in long term studies in the rat and the mouse.
Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at doses of aciclovir greatly in excess of those employed therapeutically. Two generation studies in mice did not reveal any effect of orally administered aciclovir on fertility.
Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rats, rabbits or mice.
In a non-standard test in rats, foetal abnormalities were observed, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.
6. Pharmaceutical particulars
6.1 List of excipients
Poloxamer 407
Cetostearyl alcohol
Sodium lauryl sulfate
White soft paraffin
Liquid paraffin
Propylene glycol
Purified water
Arlacel 165 (containing glycerol monostearate and polyoxyethylene stearate)
Dimeticone 20
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25°C. Do not refrigerate.
6.5 Nature and contents of container
Collapsible aluminium tubes with plastic screw caps
Pack size: 2g or 10g tubes
6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Administrative data
7. Marketing authorisation holder
The Wellcome Foundation Ltd
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT
8. Marketing authorisation number(s)
PL 00003/0180
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 28 October 1999
Date of latest renewal: 28 October 2004
10. Date of revision of the text
11 December 2013
11. Legal status
POM
